Stivarga Regulatory Post-Marketing Surveillance Study in Korea
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Neoplasms
PROVIDER: 2164182 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.
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Project description:IntroductionIn 2017, a quadrivalent inactivated split-virion influenza vaccine (QIV; Vaxigrip Tetra®, Sanofi) was licensed in South Korea for active immunization against influenza A and influenza B viruses in individuals aged 3 years or older, which was subsequently extended to individuals aged 6 months or older in 2018. Post-marketing surveillance trials are mandatory in South Korea to retain drug licensure. Here, we assessed the safety of QIV in routine clinical practice in South Korea.MethodsThis was an open, multicenter, observational, active safety surveillance study conducted between 20 June 2017 and 19 June 2021 at 10 study sites in South Korea in individuals aged 3 years or older who received a single dose of QIV during a routine healthcare visit. The participants or their legally acceptable representatives were instructed to record any adverse reactions (solicited events) and unsolicited non-serious adverse events (AE) in diary cards, and notify study investigators in case of serious adverse events (SAE).ResultsOverall, 663 participants were included in this study. There were no AEs leading to study termination, and no SAEs reported. Injection site pain (278 [41.9%]) was the most frequent solicited injection site reaction, with myalgia (250 [37.7%]) and malaise (236 [35.6%]) the most frequent solicited systemic reactions. Grade 3 solicited injection site and systemic reactions were reported by 8 (1.2%) and 13 (2.0%) participants, respectively; most participants with solicited reactions recovered without the need for further action. Overall, 39 (5.9%) participants experienced 49 unsolicited non-serious AEs with the most frequently reported being nasopharyngitis (19 [2.9%]). Grade 3 unsolicited non-serious adverse events were reported in 1 (0.2%) participant. None of the unsolicited non-serious AEs were considered to be related to QIV.ConclusionThis post-marketing surveillance study confirms that QIV is well tolerated and has an acceptable safety profile in routine practice in South Korea. No unexpected safety concerns were identified.Trial registrationClinicalTrials.gov identifier NCT05406180.
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Project description:IntroductionGolimumab is a human monoclonal antibody that inhibits tumor necrosis factor-α (TNF-α). Inhibition of TNF-α by golimumab inhibits the inflammatory response, thereby modulating the immune response in immune-mediated inflammatory diseases. Although the efficacy of golimumab has been demonstrated in randomized controlled trials (RCTs), various patient populations, such as those at high risk of infection, including those with latent tuberculosis and various comorbidities, or on co-administered medications, were excluded from the RCTs. Therefore, safety cannot be sufficiently evaluated by RCTs in the patient group with heterogenous characteristics. The aim of this study was to assess the safety and effectiveness of golimumab in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondyloarthritis (AS) in a real-world setting in Korea.MethodsWe conducted an open-label, prospective, non-interventional study as post-marketing surveillance. Safety was evaluated by collecting and recording adverse events, and effectiveness was evaluated by assessing disease activity using DAS28-CRP, DAS28-ESR, ACR20, and ASAS20 outcome measures. Multiple logistic regression was performed to identify factors associated with the incidence of adverse events, and changes in disease activity scores from baseline were analyzed using the Wilcoxon signed-rank test.ResultsA total 673 patients were enrolled, of whom 621 were included in the safety analysis. During the study, 97 adverse drug reactions (ADRs) were reported in 62 patients (10.0%). The most frequently reported ADRs were related to infection, including nasopharyngitis (0.8%), upper respiratory tract infection (0.6%), and herpes zoster (0.5%). The mean (± standard deviation) changes from baseline in global disease activity at weeks 12 and 24 were - 3.37 ± 2.529 and - 3.68 ± 2.404, respectively, with statistical significance. In those patients with RA, 72.5 and 47.0% of individuals had a good response based on DAS28-CRP and DAS28-ESR outcomes at week 24. At week 24, 71.4% of patients with PsA had an ACR20 response and 72.9% of patients with AS had an ASAS20 response.ConclusionIn the real-world setting, golimumab was safe and effective in Korean patients with RA, PsA, and AS.
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Project description:A post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer treated with Erbitux as final evaluable cases.
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Project description:BackgroundThe aim of this study was to assess the long-term safety and efficacy of sapropterin in a real-world setting in Japanese patients with tetrahydrobiopterin (BH4)-responsive phenylketonuria.MethodsThis post-marketing surveillance study enrolled all of the patients in Japan with confirmed BH4-responsive PKU who were administrated sapropterin between July 2008 and October 2017. Patients were observed at least every 3 months during follow up, with key data collected on treatment exposure/duration, effectiveness according to physician's judgement, serum phenylalanine levels, and adverse events.ResultsOf 87 enrolled patients, 85 patients (male, 42.4%; outpatients, 96.5%) were included in the safety and efficacy analysis sets. Treatment started at age <4 years in 43 (50.6%) patients and the most common starting daily dose was 5-10 mg/kg (n = 41, 48.2%) with the overall duration of treatment between 0.2 and 17.2 years. Serum phenylalanine levels, according to loading tests, reduced from a baseline level of 9.66 mg/dL (range 0.48-36.80 mg/dL) by >30% in 84 patients. Treatment was deemed effective in 79 of 85 patients (92.9%, 95% confidence interval: 85.3-97.4). One patient (1.2%) experienced an adverse drug reaction (alanine aminotransferase increased) 50 days after the start of administration, which resolved without complications with continued treatment.ConclusionsSapropterin appears well tolerated and highly effective in Japanese patients treated in a real-world setting, including those who start treatment at age <4 years and pregnant women.
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Project description:IntroductionHepatitis A, caused by hepatitis A virus (HAV), is one of the leading causes of acute hepatitis in South Korea. Avaxim® 160U is an inactivated hepatitis A vaccine that has been proven to be highly effective and well tolerated. It is licensed for use in more than 90 countries, and was approved for use in South Korea in 2011. Clinical trial and approval processes may not fully assess the safety and efficacy of a vaccine. Post-marketing surveillance (PMS) aims to provide a complete safety profile of a vaccine in a real-life setting. PMS trials are mandatory in South Korea to retain drug licensure.MethodsThis post-marketing observational study (NCT01838070) was conducted over 4 years at 16 centres in South Korea, and aimed to observe and record all types of adverse events (AE) occurring in an adult population after vaccination with Avaxim® 160U. This included solicited events, unsolicited non-serious events, unexpected events and serious events.ResultsCase report forms were collected from 614 vaccinees, all of whom completed 30 days of follow-up post-vaccination, of whom 36 (5.9%) experienced 53 solicited and unsolicited AEs, 17 (2.8%) experienced 22 of the solicited AEs, while there were no reports of AEs of severe intensity. A total of 31 unsolicited AEs were reported in 22 patients (3.6%), and no unexpected adverse drug reactions were reported.ConclusionNo new safety issues were identified and the safety profile obtained from this study was comparable to that of previous studies for HAV vaccine.Trial registrationClinicalTrials.gov identifier, NCT01838070.FundingSanofi Pasteur.
| S-EPMC6374234 | biostudies-literature
Project description:This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.
| 2377734 | ecrin-mdr-crc
Project description:Highlights • Active post-marketing safety surveillance on ROTASIIL, an oral rotavirus vaccine, was conducted in 9940 infants in India.• Three doses of ROTASIIL were administered at 6, 10 and 14 weeks of age, along with other EPI vaccines.• Most of the AEs were pyrexia and injection site reactions caused by the concomitant injectable vaccines.• No case of intussusception (IS) was reported.• ROTASIIL was safe and well tolerated. Background ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017. This post-marketing surveillance (PMS) was conducted to collect real-world data on the safety of ROTASIIL in India. Methods Observational, active PMS was conducted in approximately 10,000 infants aged ≥ 6 weeks. ROTASIIL was administered as a 3-dose regimen, at least 4 weeks apart, beginning at ≥ 6 weeks of age concomitantly with other Expanded Programme on Immunization (EPI) vaccines. Participants were followed for one month after the last dose. The adverse events (AEs) and serious adverse events (SAEs), including intussusception (IS) reported during the follow up period were collected. Findings A total of 9940 infants were enrolled and were considered for safety analysis. Around 9913 (99.7 %) infants received 2 doses, while 9893 (99.5 %) infants completed all three doses. Total 3693 AEs were reported in 2516 (25.3 %) participants. Most of these AEs were pyrexia (78.01 % of events) and injection-site reactions (19.14 % of events). Nearly all AEs were causally unrelated to orally administered ROTASIIL and could be caused by the concomitant injectable vaccines. Only 4 AEs (2 events of vomiting and 1 event each of discomfort and pyrexia) in 4 (<0.1 %) participants could be related to ROTASIIL. AEs were of mild or moderate severity and all resolved without any sequelae. A total of 2 SAEs (acute otitis media and skull fracture) were reported in 2 (<0.1 %) participants and were not related to ROTASIIL and recovered without sequelae. No case of IS was reported. Interpretation ROTASIIL was safe and well tolerated in this study. No safety concerns were reported. Funding The study was funded by SIIPL which is the manufacturer of the study product.
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Project description:IntroductionTETRAXIM™ (Sanofi), a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine, has been licensed in South Korea since 2009. In accordance with the Ministry of Food and Drug Safety regulations, this post-marketing surveillance (PMS) study evaluated the safety of the DTaP-IPV vaccine in real-world clinical practice in infants and children who received it as either a part of the three-dose primary series dose at 2, 4, and 6 months or school entry booster between 4 and 6 years of age.MethodsThis multicenter, observational, PMS study was conducted in real-world practice in South Korea for 6 years (2009-2015) in participants aged between 2 months and 6 years. The study outcomes included solicited reactions, unsolicited adverse events (AEs)/adverse drug reactions (ADRs), unexpected AEs/ADRs, and serious AEs (SAEs)/ADRs.ResultsData from 647 participants was included in the safety analysis. Overall, 268 AEs were reported by 181 (28%) participants: 47 (17.5%) solicited reactions, 220 (82.1%) unsolicited AEs, and 1 (0.4%) unsolicited ADR. A total of 48 AEs (including 47 solicited reactions) were reported to have a causal relationship with the DTaP-IPV vaccine and were reported by 36 (5.6%) participants. A total of 212 unexpected AEs were reported by 152 (23.5%) participants, none of which had a causal relationship with the DTaP-IPV vaccine. Neither immediate AEs nor SAEs were reported during the study. Among the participants who reported AEs, 220 (34%) were on concomitant medications. Most AEs were of mild intensity, and all participants recovered.ConclusionNo safety concerns related to the DTaP-IPV vaccine in a real-world setting were raised in participants aged 2-6 months for the primary series and 4-6 years for the school-entry booster dose in the Korean population. The DTaP-IPV vaccine was well tolerated and can be continued as part of routine immunization programs in infants and children.Trial registrationNCT01437423.
| S-EPMC9334467 | biostudies-literature